Device and Method for Automatic Data Acquisition and/or Detection

ABSTRACT

Methods and system for providing diabetes management including automatic time acquisition protocol and expiration date detection are provided.

RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 14/829,611 filed Aug. 18, 2015, which is a continuation of U.S.patent application Ser. No. 12/031,660 filed Feb. 14, 2008, which claimspriority under § 35 U.S.C. 119(e) to U.S. Provisional Patent ApplicationNo. 60/890,161 filed Feb. 15, 2007, entitled “Device And Method ForAutomatic Data Acquisition And/Or Detection”, the disclosures of each ofwhich are incorporated herein by reference for all purposes.

BACKGROUND

In diabetes management, there exist devices which allow diabeticpatients to measure the blood glucose levels. One such device is ahand-held electronic meter such as blood glucose meters such asFreestyle® blood glucose monitoring system available from AbbottDiabetes Care Inc., of Alameda, Calif. which receives blood samples viaenzyme-based test strips. Typically, the patient lances a finger oralternate body site to obtain a blood sample, applies the drawn bloodsample to the test strip, and the strip is inserted into a test stripopening or port in the meter housing. The blood glucose meter converts acurrent generated by the enzymatic reaction in the test strip to acorresponding blood glucose value which is displayed or otherwiseprovided to the patient to show the level of glucose at the time oftesting.

Such periodic discrete glucose testing helps diabetic patients to takeany necessary corrective actions to better manage diabetic conditions.Presently available glucose meters have limited functionalities (forexample, providing the glucose value measured using the test strip andstoring the data for subsequent recall or display) and do not provideany additional information or capability to assist patients in managingdiabetes. For example, Type-1 diabetic patients who require periodicinfusion or injection of insulin, typically use glucose meters inaddition to, for example, wearing an external infusion device, or a pentype injection device. Also, in the case of external infusion devices,because the strip port on the meter receives the test strip (which isgenerally not a water tight seal), it is not desirable to incorporatethe discrete glucose meter functionalities to the housing of theexternal infusion devices.

Presently available external infusion devices typically include an inputmechanism such as buttons through which the patient may program andcontrol the infusion device. Such infusion devices also typicallyinclude a user interface such as a display which is configured todisplay information relevant to the patient's infusion progress, statusof the various components of the infusion device, as well as otherprogrammable information such as patient specific basal profiles.

The external infusion devices are typically connected to an infusion setwhich includes a cannula that is placed transcutaneously through theskin of the patient to infuse a select dosage of insulin based on theinfusion device's programmed basal rates or any other infusion rates asprescribed by the patient's doctor. Generally, the patient is able tocontrol the pump to administer additional doses of insulin during thecourse of wearing and operating the infusion device such as for,administering a carbohydrate bolus prior to a meal. Certain infusiondevices include food database that has associated therewith, an amountof carbohydrate, so that the patient may better estimate the level ofinsulin dosage needed for, for example, calculating a bolus amount.

Programming and controlling the pump functions are typically performedby the patient using the pump user interface which includes inputbuttons and a display. Typically, depending on the type of the infusiondevice, the amount of information which is provided to the usergenerally focuses on infusion management such as programming temporarybasals, bolus calculation, and the like, in addition to the deviceoperational functions such as alerts for occlusion detection. Given thedecreasing cost of microprocessor, communication and other electroniccomponents, and increasing sophistication of patients and users ofmedical devices such as blood glucose meters, infusion devices, andcontinuous glucose monitoring systems, it would be desirable to provideadditional features and functionalities to improve health relatedmanagement by the user using these medical devices.

SUMMARY

In accordance with the various embodiments of the present disclosure,there are provided methods and system for providing robustfunctionalities for a therapy management system including infusiondevices and analyte monitoring systems including continuous glucosemonitoring systems and discrete blood glucose meters with improvedcapabilities.

These and other objects, features and advantages of the presentdisclosure will become more fully apparent from the following detaileddescription of the embodiments, the appended claims and the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram illustrating a therapy management system forpracticing one embodiment of the present disclosure;

FIG. 2 is a block diagram of a fluid delivery device of FIG. 1 in oneembodiment of the present disclosure;

FIG. 3 is a flowchart illustrating the time zone detection procedure inthe therapy management system in one embodiment of the presentdisclosure;

FIG. 4 is a flowchart illustrating the time zone detection procedure inthe therapy management system in another embodiment of the presentdisclosure;

FIG. 5 is a flowchart illustrating the device synchronization procedurein the therapy management system in one embodiment of the presentdisclosure;

FIG. 6 is a flowchart illustrating device condition notificationfunction in the therapy management system in one embodiment of thepresent disclosure;

FIG. 7 is a flowchart illustrating automatic time information detectionfunction incorporated in a medical device such as a blood glucose meterin one embodiment of the present disclosure;

FIG. 8 is a flowchart illustrating automatic time information detectionfunction incorporated in a medical device such as a blood glucose meterin another embodiment of the present disclosure; and

FIGS. 9A-9C illustrate embodiments of automatic expiration detectionfunction on blood glucose meter test strips in accordance with oneembodiment of the present disclosure.

DETAILED DESCRIPTION

As described below, within the scope of the present disclosure, thereare provided user interface features associated with the operation ofthe various components or devices in a therapy management system such asautomatic time change based functions, automatic expiration datedetection on test strips, for example, synchronization of the componentsin the therapy management system, user interface changes based on theuser configuration, notification functions for programmable eventsassociated with the therapy management, and voice enabled communicationbetween devices in the therapy management system.

FIG. 1 is a block diagram illustrating a therapy management system forpracticing one embodiment of the present disclosure. Referring to FIG.1, the therapy management system 100 includes an analyte monitoringsystem 110 operatively coupled to a fluid delivery device 120, which maybe in turn, operatively coupled to a remote terminal 140. As shown inthe Figure, the analyte monitoring system 110 is, in one embodiment,coupled to the patient 130 so as to monitor or measure the analytelevels of the patient. Moreover, the fluid delivery device 120 iscoupled to the patient using, for example, an infusion set and tubingconnected to a cannula (not shown) that is placed transcutaneouslythrough the skin of the patient so as to infuse medication such as, forexample, insulin, to the patient.

Referring to FIG. 1, the analyte monitoring system 110 in one embodimentmay include one or more analyte sensors subcutaneously positioned suchthat at least a portion of the analyte sensors are maintained in fluidcontact with the patient's analytes. The analyte sensors may include,but are not limited to short term subcutaneous analyte sensors ortransdermal analyte sensors, for example, which are configured to detectanalyte levels of a patient over a predetermined time period, and afterwhich, a replacement of the sensors is necessary.

The one or more analyte sensors of the analyte monitoring system 110 iscoupled to a respective one or more of a data transmitter unit which isconfigured to receive one or more signals from the respective analytesensors corresponding to the detected analyte levels of the patient, andto transmit the information corresponding to the detected analyte levelsto a receiver device, and/or fluid delivery device 120. That is, over acommunication link, the transmitter units may be configured to transmitdata associated with the detected analyte levels periodically, and/orintermittently and repeatedly to one or more other devices such as thefluid delivery device 120 and/or the remote terminal 140 for furtherdata processing and analysis.

In one aspect, each of the one or more receiver devices of the analytemonitoring system 110 and the fluid delivery device 120 includes a userinterface unit which may include a display unit, an audio output unitsuch as, for example, a speaker, or any other suitable user interfacemechanism for displaying or informing the user of such devices.

The transmitter units of the analyte monitoring system 110 may in oneembodiment be configured to transmit the analyte related datasubstantially in real time to the fluid delivery device 120 and/or theremote terminal 140 after receiving it from the corresponding analytesensors such that the analyte level such as glucose level of the patient130 may be monitored in real time. In one aspect, the analyte levels ofthe patient may be obtained using one or more of discrete blood glucosetesting devices such as blood glucose meters that employ glucose teststrips, or continuous analyte monitoring systems such as continuousglucose monitoring systems. In a further embodiment, the analytemonitoring system 110 may include a blood glucose meter such asFreeStyle® and Precision meters available from Abbott Diabetes CareInc., of Alameda Calif. The blood glucose meter may be used to calibratethe sensors in the analyte monitoring system 110. Exemplary analytesystems that may be employed are described in, for example, U.S. Pat.Nos. 6,134,461, 6,175,752, 6,121,611, 6,560,471, 6,746,582, andelsewhere, the disclosures of which are herein incorporated byreference.

Analytes that may be monitored, determined or detected in the analytemonitoring system 110 include, for example, acetyl choline, amylase,amylin, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase(e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growthhormones, hormones, ketones, lactate, measures for oxidative stress(such as 8-iso PGF2gamma), peroxide, prostate-specific antigen,prothrombin, RNA, thyroid stimulating hormone, and troponin. Theconcentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), biguanides, digitoxin, digoxin,drugs of abuse, GLP-1, insulin, PPAR agonists, sulfonylureas,theophylline, thiazolidinediones, and warfarin, may also be determined.

Moreover, within the scope of the present disclosure, the transmitterunits of the analyte monitoring system 110 may be configured to directlycommunicate with one or more of the remote terminal 140 or the fluiddelivery device 120. Furthermore, within the scope of the presentdisclosure, additional devices may be provided for communication in theanalyte monitoring system 110 including additional receiver/dataprocessing units, remote terminals (such as a physician's terminaland/or a bedside terminal in a hospital environment, for example).

In addition, within the scope of the present disclosure, one or more ofthe analyte monitoring system 110, the fluid delivery device 120 and theremote terminal 140 may be configured to communicate over a wirelessdata communication link such as, but not limited to RF communicationlink, Bluetooth® communication link, infrared communication link, or anyother type of suitable wireless communication connection between two ormore electronic devices, which may further be uni-directional orbi-directional communication between the two or more devices.Alternatively, the data communication link may include wired cableconnections such as, for example, but not limited to RS232 connection,USB connection, or serial cable connection.

The fluid delivery device 120 may include in one embodiment, but notlimited to, an external infusion device such as an external insulininfusion pump, an implantable pump, a pen-type insulin injector device,a patch pump, an inhalable infusion device for nasal insulin delivery,or any other type of suitable delivery system. In addition, the remoteterminal 140 in one embodiment may include for example, a desktopcomputer terminal, a data communication enabled kiosk, a laptopcomputer, a handheld computing device such as a personal digitalassistant (PDAs), or a data communication enabled mobile telephone.

Referring back to FIG. 1, in one embodiment, the analyte monitoringsystem 110 includes a strip port configured to receive a test strip forcapillary blood glucose testing. In one aspect, the glucose levelmeasured using the test strip may in addition, be configured to provideperiodic calibration of the analyte sensors of the analyte monitoringsystem 110 to assure and improve the accuracy of the analyte levelsdetected by the analyte sensors.

Referring yet again to FIG. 1, in one embodiment of the presentdisclosure, the fluid delivery device 120 may be configured to include avoice signal activation/generation unit for voice communication with theremote terminal 140 configured as a voice device such as a mobiletelephone, a voice enabled personal digital assistant, a Blackberrydevice, or the like. For example, in one embodiment, the communicationbetween the fluid delivery device 120 and the remote terminal 140 may bevoice based such that the information or data output to the user fromthe fluid delivery device 120 is configured to be transmitted to theuser's telephone. In turn, the fluid delivery device 120 mayadditionally be configured to receive voice commands from the remoteterminal 140 configured as a telephone or any other voice signalcommunication device (such as personal computers or PDAs with voicesignal capabilities).

In this manner, in one embodiment, the user interface of the fluiddelivery device 120 may be configured with the voice signalactivation/generation unit such that, output information for the user isconverted into a voice signal and transmitted to the voice signalenabled remote terminal 140. For example, when the fluid delivery device120 detects an alarm condition, the fluid delivery device 120 isconfigured to initiate a telephone call to the user's telephone (remoteterminal 140), and when the user picks up the telephone line, the useris provided with a voice signal representing the alarm condition.

In a further embodiment, for certain predetermined patient conditions,the fluid delivery device 120 may be configured to initiate a telephonecall directly to a preprogrammed telephone number of a health carephysician, a local hospital, or emergency medical care facilities, inaddition to or instead of initiating a telephone call to the user of thefluid delivery device 120.

In addition, within the scope of the present disclosure, interaction andprogramming of the fluid delivery device 120 may be exclusively orpartially exclusively performed over the user's telephone in voicecommunication with the fluid delivery device 120. That is, when the userwishes to calculate a carbohydrate bolus in the fluid delivery device120, the user may dial a predetermined number using the user's telephone(remote terminal 140) to connect with the fluid delivery device 120, andthe user may provide voice commands to the fluid delivery device 120 viathe telephone connection between the user's telephone (remote terminal140) and the fluid delivery device 120.

FIG. 2 is a block diagram of a fluid delivery device of FIG. 1 in oneembodiment of the present disclosure. Referring to FIG. 2, the fluiddelivery device 120 in one embodiment includes a processor 210operatively coupled to a memory unit 240, an input unit 220, a displayunit 230, an output unit 260, and a fluid delivery unit 250. In oneembodiment, the processor 210 includes a microprocessor that isconfigured to and capable of controlling the functions of the fluiddelivery device 120 by controlling and/or accessing each of the variouscomponents of the fluid delivery device 120. In one embodiment, multipleprocessors may be provided as safety measure and to provide redundancyin case of a single processor failure. Moreover, processing capabilitiesmay be shared between multiple processor units within the fluid deliverydevice 120 such that pump functions and/or control may be performedfaster and more accurately.

Referring back to FIG. 2, the input unit 220 operatively coupled to theprocessor 210 may include a jog dial key pad buttons, a touch padscreen, or any other suitable input mechanism for providing inputcommands to the fluid delivery device 120. More specifically, in case ofa jog dial input device, or a touch pad screen, for example, the patientor user of the fluid delivery device 120 will manipulate the respectivejog dial or touch pad in conjunction with the display unit 230 whichperforms as both a data input and output unit. The display unit 230 mayinclude a touch sensitive screen, an LCD screen, or any other types ofsuitable display unit for the fluid delivery device 120 that isconfigured to display alphanumeric data as well as pictorial informationsuch as icons associated with one or more predefined states of the fluiddelivery device 120, or graphical representation of data such as trendcharts and graphs associated with the insulin infusion rates, trend dataof monitored glucose levels over a period of time, or textualnotification to the patients.

In one embodiment, the alphanumeric representation displayed on thedisplay unit 230 may be configured to be modified by the user of thefluid delivery device such that the size of the displayed number orcharacter may be adjusted to suit the user's visual needs. For example,in one embodiment, the user may apply font size adjustment request viathe input unit 220 to instruct the processor 210 to modify the size ofthe displayed number or character on the display unit 230. In oneaspect, the font size may be increased or decreased for each character,value or word displayed on the display unit 230. Alternatively, the fontsize adjustment may be applied globally to all output settings, forexample, under the control of the processor 210 such that the usersetting of the size adjustment may be configured to apply tosubstantially all displayed values or characters on the display unit 230of the fluid delivery device 120 (FIG. 1).

Moreover, referring back to FIG. 2, in a further aspect of the presentdisclosure, the relative size adjustment of the displayed character orvalue may be determined by the processor 210 so that the relative sizeadjustment may be implemented to the output display on the display unit230. In this manner, depending upon the type or configuration of thedisplay unit 230 (whether bit map or icon type display), in oneembodiment, the display size adjustment may be implemented within thepredetermined size restrictions for the respective value or character.For example, a 10% relative increase in the font size for display areadesignated for insulin dosage level may correspond to a 5% relativeincrease in the size of the display area designated for the insulindelivery time display. In one embodiment, the processor 210 may beconfigured to determine the relative size modification for each area ofthe display unit 230 based on the user inputted size adjustment valuesto appropriately apply the relative size differential adjustment.

In a further aspect, the processor 210 may be configured to temporarilyincrease the font size displayed on the display unit 230 based on theuser input commands such that the user requested size modification onthe display unit 230 may be implemented only for the displayed screen atthe time the user input commands for size adjustment is received by theprocessor 210. In this manner, the processor may be configured to revertto the previously programmed display size settings for the display unit230 when the user is no longer viewing the particular displayed screenfrom which the user has requested font size adjustment.

In addition, the user interface of the receiver unit of the analytemonitoring system 110 (FIG. 1) may be configured with similar sizeadjustment capabilities so as to allow the user to instruct thecontroller or processor of the analyte monitoring system 110 toappropriately adjust the size of the displayed character or value on thedisplay unit of the analyte monitoring system 110.

In a further embodiment, the display unit 230 may be configured todisplay an indication or marker for the type of insulin or othermedication being used by the fluid delivery device 120 such as, forexample, Symlin and Byetta. Such a marker may, in one embodiment, beassociated with a predefined icon or character for display on thedisplay unit 230. In addition, within the scope of the presentdisclosure, the information associated with the displayed marker orindication may be stored in the memory unit 240 so that the user mayretrieve this information as desired. In addition, an indication or amarker for shift work may be programmed in the fluid delivery device 120(FIG. 1) such that shift workers using the fluid delivery device 120 mayalign days and nights upon command based on the markers.

For example, if a user worked nightshifts on Mondays and Tuesdays anddayshifts on Thursdays and Fridays, this daily work pattern informationmay be stored, identified or marked in the fluid delivery device 120 toprovide additional data management functionalities and a more robusttherapy analysis. For example, meal times such as breakfasts, forexample, at 8 pm on Monday and 9 pm on Tuesday (during the nightshifts)may be aligned with the breakfasts at 7 am on Thursday and 8 am onFriday. In this manner, the user may conveniently access meal (e.g.,breakfast) related data and associated therapy information inconjunction with the operation of the fluid delivery device 120. Thismay assist the user in improving upon the user's diet such as the dailyfood intake.

Referring to FIG. 2, the output unit 260 operatively coupled to theprocessor 210 may include an audible alarm or alarms including one ormore tones and/or preprogrammed or programmable tunes or audio clips, orvibratory alert features having one or more pre-programmed orprogrammable vibratory alert levels.

In addition, in one embodiment of the present disclosure, each alertevent or alarm event may be programmed with combined notificationfeatures such that, depending upon the level of importance associatedwith each alert or alarm, a combination of vibratory, audible, ordisplayed indications may be provided to the user using the display unit230 in combination with the output unit 260.

For example, the processor 210 may be configured to provide combinedvibratory and increasingly audible alerts on the output unit 260 inaddition to intermittently flashing background light on the display unit230 for one or more predetermined alarms that require immediate userattention. An example may include unexpected pressure increase in theinfusion tubing which may indicate an occlusion or other undesirablecondition that the user should be immediately notified. The processor210 may be configured such that the alarm or alert may be automaticallyreasserted within a predetermined time period in the event theassociated alarm or alert condition has not been cleared by the user. Inaddition, each alert/alarm feature may be individually programmed toinclude a wide selection of tones, audible levels, vibratory strength,and intensity of visual display.

In a further aspect, the fluid delivery device 120 may be configured toprovide an alarm or alert indication associated with a change intemperature. That is, when the fluid delivery device 120 which containsthe insulin (for example, in a reservoir) experiences a rise or drop intemperature, such change in the temperature may have an adverse effecton the insulin contained within the device 120. Accordingly, atemperature sensor may be coupled to the processor 210 of the fluiddelivery device 120 to detect the operating condition of the fluiddelivery device 120 and to notify the user of changes in thetemperature, when, for example, the temperature change reaches apredetermined threshold level that may potentially have an adverseimpact upon the efficacy of the insulin being delivered.

Also shown in FIG. 2 is the fluid delivery unit 250 which is operativelycoupled to the processor 210 and configured to deliver the insulin dosesor amounts to the patient from the insulin reservoir or any other typesof suitable containment for insulin to be delivered (not shown) in thefluid delivery device 120 via an infusion set coupled to asubcutaneously positioned cannula under the skin of the patient.

Referring yet again to FIG. 2, the memory unit 240 may include one ormore of a random access memory (RAM), read only memory (ROM), or anyother type of data storage unit that is configured to store data as wellas program instructions for access by the processor 210 and execution tocontrol the fluid delivery device 120 and/or to perform data processingbased on data received from the analyte monitoring system 110, theremote terminal 140, the patient 130 or any other data input source.

FIG. 3 is a flowchart illustrating the time zone detection procedure inthe therapy management system in one embodiment of the presentdisclosure. Referring to FIG. 3, the fluid delivery device 120 (FIG. 1)may be configured to transmit a location position request (310) to forexample, a global positioning system (GPS). Thereafter, the locationinformation is received (320) by the processor 210 of the fluid deliverydevice 120. The processor 210 is further configured to determine whetherthe location information has changed (330). That is, the processor 210in one embodiment is configured to compare the receive locationinformation which may include a current time zone information associatedwith the location of the fluid delivery device 120, with the previouslystored and operating time zone information in the fluid delivery device120 in operation.

Referring back, if it is determined that the location information hasnot changed, then the routine terminates. On the other hand, if it isdetermined that the fluid delivery device location information haschanged, then, the location change information is output (340) to theuser on the display unit 230, for example. Thereafter, the processor 210may be configured to generate a user prompt or notification to modifythe time zone information (350) of the fluid delivery device 120 suchthat it is updated to the new location where the fluid delivery device120 is operating.

For example, when the fluid delivery device 120 is programmed withpredetermined basal profiles and/or bolus functions that are time basedand associated with an internal clock of the fluid delivery device 120,it may be desired to modify some or all of the time based insulindelivery profiles programmed in the fluid delivery device 120 so as tocorrespond to the location of the fluid delivery device 120. Morespecifically, if a user is traveling from a first location to a secondlocation in which one or more time zones are traversed, e.g., by way ofexample from San Francisco to Paris, given the time difference, the mealtimes, and sleep times, for example, will change. In this case, it maybe desirable to modify the preprogrammed time based insulin deliveryprofiles so that they are synchronized with the user events such asmeals and sleep times.

Referring back to FIG. 3, in one embodiment, the user responds to thetime based programming change prompt provided by the processor 210, thenthe processor 210 may be configured in one embodiment, to propagate thetime change associated with the preprogrammed insulin delivery profileand notify the user to confirm the changes, prior to implementing themodification to the delivery profiles and any associated alerts ornotifications. For example, in the case where the user has programmed tobe alerted at a particular time of day, e.g., noon each day, for a bolusdetermination prior to lunch, the processor 210 in one embodiment isconfigured to either modify the internal clock of the fluid deliverydevice 120 or alternatively, modify the programmed alert for bolusdetermination so as to correspond to the new location of the user andthe fluid delivery device 120.

In another embodiment, the fluid delivery device 120 may be configuredto include a time zone detection unit, such as for example, theprocessor 210 may be configured to communicate with a geographicallocation change detection mechanism (e.g., an atomic clock) operativelycoupled to the processor 210 for performing the time zone detectionprocedure as described above in conjunction with FIG. 3. In addition,the analyte monitoring system 110 may be configured to include a timezone detection unit as described above to automatically or based on apreprogrammed procedure, detect any location change associated with theanalyte monitoring system 110. In this manner, the analyte monitoringsystem 110 may be configured to automatically or based on apreprogrammed procedure, implement modifications to functions associatedwith the operation of the analyte monitoring system 110 that aretemporally associated with the time of day information.

FIG. 4 is a flowchart illustrating the time zone detection procedure inthe therapy management system in another embodiment of the presentdisclosure. Referring to FIG. 4, the fluid delivery device 120 (FIG. 1)may be configured to transmit a location position request (410) to forexample, a global positioning system (GPS). Thereafter, the locationinformation is received (420) by the processor 210 of the fluid deliverydevice 120. The processor 210 is further configured to determine whetherthe location information has changed (430). That is, the processor 210in one embodiment is configured to compare the receive locationinformation which may include a current time zone information associatedwith the location of the fluid delivery device 120, with the previouslystored and operating time zone information in the fluid delivery device120 in operation.

Referring back, if it is determined that the location information hasnot changed, then the routine terminates. On the other hand, if it isdetermined that the fluid delivery device location information haschanged, then, the processor 210 in one embodiment is configured toretrieve one or more time based programmed functions (440) from thememory unit 240 of the fluid delivery device 120, for example.

Thereafter, the processor 210 may be further configured to modify theretrieved time based preprogrammed functions in accordance with thelocation change information received (450). Then, the modified retrievedfunctions are provided to the user (460) on the display unit 230, forexample, to request confirmation of the time based adjustments, prior tothe processor 210 executing the modified retrieved functions.

In addition, in one embodiment of the present disclosure, the fluiddelivery device 120 may be configured to detect for daylight savingstime and the processor 210 may be configured to either automaticallyexecute the time change in the internal clock of the fluid deliverydevice, and/or provide a user notification to accept such time basedchange so that the operation of the fluid delivery device 120 performingtime based programs are updated with any time based change in theinsulin delivery system 120 operating environment.

Within the scope of the present disclosure, the fluid delivery device120 may be configured to receive location information from anypositioning system which provides updated time information based onlocation. The fluid delivery device 120 may be configured with apositioning transceiver that is configured to transmit locationinformation requests to a satellite network, for example, and to receivethe location information therefrom.

Alternatively, the fluid delivery device 120 may be configured to updateits location information locally upon synchronization with anotherdevice operating in the local (or at the new location). This may includea host computer terminal connectable to the fluid delivery device 120such as, for example, the remote terminal 140 (FIG. 1), the analytemonitoring system 110, or any other electronic device operating in thenew location with communication capabilities with the fluid deliverydevice 120 such as a cellular telephone, a personal digital assistant,and the like.

In addition, within the scope of the present disclosure, the procedureand processes described in conjunction with FIGS. 3-4 associated withlocation change information and corresponding modification to the timebased preprogrammed functions in the fluid delivery device 120 may beprovided to the analyte monitoring system 110 such that the analytemonitoring system 110 is also configured to receive new locationinformation and correspondingly perform modifications to any time basedpreprogrammed functions.

FIG. 5 is a flowchart illustrating the device synchronization procedurein the therapy management system in one embodiment of the presentdisclosure. Referring to FIG. 5, in one embodiment the fluid deliverydevice 120 (FIG. 1) may be configured to detect a synchronizationrequest (510) from another device such as the remote terminal 140 or theanalyte monitoring system 110 (FIG. 1). Thereafter, data communicationconnection is established (520) between the fluid delivery device 120and the synchronization requesting device. In one embodiment, the fluiddelivery device 120 is configured to verify the authenticity or identityof the device requesting synchronization, and upon synchronizationapproval, the fluid delivery device 120 is configured to establishcommunication with the synchronization requesting device.

In addition, within the scope of the present disclosure, the fluiddelivery device 120 may be configured to periodically or at apredetermined time interval, establish communication connection withanother device for synchronization. Alternatively, the fluid deliverydevice may be configured to attempt communication connection whenanother device for synchronization is detected within a predefineddistance from the location of the fluid delivery device 120.

Referring back to FIG. 5, the fluid delivery device 120 is configured inone embodiment to transmit its programmed and operating settings to theconnected device (530), and the connected device is configured to updateand store the data received from the fluid delivery device 120 based onpredetermined conditions (540). For example, the predeterminedconditions may include a predefined set of rules associated with thetype of data from the fluid delivery device 120 to be updated such ashistorical infusion related information, programmed functions in thefluid delivery device 120 such as bolus calculations, temporarily basalprofiles, programmed basal profiles, insulin usage level, and any otherinformation that is associated with the user.

In this manner, in one embodiment of the present disclosure, periodicsynchronization of the fluid delivery device 120 settings and functionsmay be synchronized to another device so that when the user replaces thefluid delivery device 120, the new or upgrade fluid delivery device maybe easily and readily programmed to the user's specification. Thesynchronization described above may be configured to be performedperiodically at a regular interval such as, once a week, once per day,when certain predefined criteria are met such as when the devices arewithin a predetermined distance from each other, and/or upon usercommand.

In addition, within the scope of the present disclosure, the fluiddelivery device 120 may be configured with any communication protocolwhich would allow data transfer between the fluid delivery device 120and the synchronizing device. This may include, wired or wirelesscommunication including for example, Bluetooth® protocol, 802.1xprotocol, USB cable connection and the like.

FIG. 6 is a flowchart illustrating device condition notificationfunction in the therapy management system in one embodiment of thepresent disclosure. Referring to FIG. 6 the fluid delivery device 120may be configured to detect a notification condition (610). For example,the processor 210 may be configured to detect such notificationconditions at a preprogrammed time interval (such as about every 24hours, for example). Thereafter, the programmed profile associated withthe condition is retrieved (620). An example of the programmed profileassociated with the condition includes a reminder to start an overnightfast for the user.

Referring back to FIG. 6, the processor 210 in one embodiment is furtherconfigured to generate a message associated with the notificationcondition and/or the retrieved programmed profile (630), and, thegenerated message is provided to the user (640) on one or more of thedisplay unit 230 or the output unit 260. In this manner, in oneembodiment of the present disclosure, the fluid delivery device 120 maybe programmed with automatic reminders for conditions to assist the userto improve insulin therapy management.

In one embodiment, the notification condition detection may be skippedand the processor 210 may be configured to retrieve the appropriateprogrammed profile associated with notification conditions based on theuser programming of the fluid delivery device 120. Additionally, while areminder for overnight fast is described as an example, any othertherapy related reminders or device operating condition reminders may beprogrammed for execution by the processor 210 to remind the user.Examples of such reminders include, but are not limited to, infusion setreplacement reminder, battery replacement reminder, data synchronizationreminder, insulin replenishment reminder, glucose testing reminder, andthe like. In addition, within the scope of the present disclosure, theprocedure described in conjunction with FIG. 6 may be incorporated inthe analyte monitoring system 110 for programming suitable automaticreminders such as, for example, sensor replacement reminder, sensorcalibration reminder, and the like.

FIG. 7 is a flowchart illustrating automatic time information detectionfunction incorporated in a medical device such as a blood glucose meterof the analyte monitoring system 110 in one embodiment of the presentdisclosure. Referring to FIG. 7, when the medical device active state isdetected (710) for example, by the user initiated power on procedure ofthe medical device such as a blood glucose meter, a routine is called bythe processor of the medical device to automatically initiate timeacquisition protocol. That is, upon power on of the medical device, thedevice is automatically configured to perform time acquisition protocolto, among others, transmit request for time and/or date information toavailable communication channels, and upon receiving the information, tostore, update and/or otherwise set and/or display the received oracquired time/date information in the medical device (720-740).

Referring back to FIG. 7, in one embodiment, the time information isreceived at step 730, and thereafter, the received time information isstored and/or displayed on a display unit of the medical device. In oneaspect, the medical device is configured to update all previously storedtime associated data (for example, blood glucose readings taken atcertain times of the day (or week, month, or any other time period)).More specifically, in one embodiment, when the medical device such asthe blood glucose meter is activated by the user, the processor orcontroller of the glucose meter is configured to enable or activatetime/date receiver (for example, a communication component such as aradio frequency transceiver coupled to the processor of the glucosemeter). The time/date receiver in one embodiment is configured to seekor acquire automatically, upon activation, time and date informationfrom one or more available communication networks within range. Forexample, the time/date receiver may be configured to detect thetime/date information from one or more radio frequencies on public,government, or private airwaves using AM band short frequency or FM bandlong wave frequency. Alternatively, as discussed above, current localtime/date information may be received from global positioningsatellites, as well as cellular telephone networks such as GSM, CDMA,AMPS, and the like within range of the time/date receiver in the medicaldevice. Additionally, WiFi network may be used to receive the time/datainformation, if available and within range.

In this manner, in one embodiment, the medical device such as a bloodglucose meter, may be configured to automatically acquire timeinformation that is continuously broadcast on a frequency in which theantenna and the receiver of the blood glucose meter are configured tooperate. Upon obtaining and verifying the time and date information, theinternal clock function or component is updated or adjusted with theacquired time/date information and displayed to the user, for example.

In a further embodiment, the medical device such as a blood glucosemeter may be configured to use GMT time as the reference time for alllog entry (for example, for each blood glucose test performed)timestamps associated with each data stored in the medical device.Thereafter, the medical device may be configured to convert the storedGMT based time information for each log entry stored in the medicaldevice to the local time based on the location of the medical device.

FIG. 8 is a flowchart illustrating automatic time information detectionfunction incorporated in a medical device such as a blood glucose meterin another embodiment of the present disclosure. Referring to FIG. 8, inone embodiment, the automatic time acquisition protocol is initiatedbased on a detection of one or more changed or preconfigured parametersassociated with the medical device and/or the user of the medical device(810). For example, the device parameter may include a preconfiguredtime for periodically checking for time and date information (such asevery 24 hours, 48 hours, or based on a programmed calendar such as tocompensate for daylight savings time change).

Alternatively, the device parameter may include an environmentalcondition change associated with the medical device or the user, such asa detection of the medical device location such as during travel by airor a vehicle. That is, in one embodiment, the medical device may beconfigured to include an altimeter which is coupled to the processor ofthe medical device to detect a change in altitude of the medical devicelocation for example, when the user of the medical device is travelingby air. In such a case, the medical device may be configured to initiatethe time acquisition protocol to confirm or verify the time and dateinformation of the medical device (820-840).

Further, the medical device may include an accelerometer which may beconfigured to initiate the automatic time acquisition protocol on themedical device when a predetermined threshold level of accelerationforce is reached. Within the scope of the present disclosure, otherparameters may be used in conjunction with the medical device to triggerthe automatic time acquisition protocol on the medical device (820-840)such that, without user intervention, prompting, or initiating, themedical device is configured to automatically initiate time and dateinformation acquisition routine. In addition, the functionality of theautomatic time and date information acquisition may be incorporated inother medical devices such as infusion pumps, continuous glucosemonitoring devices, heart rate monitors, and the like that areconfigured to maintain a time associated log of physiological data (suchas glucose levels, insulin infusion rates, cardiac signal levels and soon) of a patient or a user.

FIGS. 9A-9C illustrate embodiments of automatic expiration detectionfunction on blood glucose meter test strips in accordance with oneembodiment of the present disclosure. Presently, test strips for usewith blood glucose meters are sold or made available in containers thatinclude the expiration date information of the test strips containedtherein. For diabetic patients or healthcare providers using glucosemeters, it is important to check the expiration information of the teststrip before testing for glucose levels so that the obtained results areaccurate.

Referring to FIGS. 9A-9C, in one embodiment, test strips may beconfigured with predefined parameters to allow automatic expiration datedetection of the test strip. In one aspect, resistance values areprovided on the test strips such that when the test strip is insertedinto the strip port of the blood glucose meter, the meter is configuredto compare the detected resistance value to a stored value ofresistance, and determine whether the inserted test strip has expired ornot. More specifically, in one embodiment, using the resistance value onthe test strip, the expiration date information may be coded, and themeter may be configured to detect the resistance value of the test stripand determine whether the test strip has expired.

In one aspect, the resistance value on the test strip may be controlledwith the ink formulation on the wake up bar and/or patterns providedthereon. Silver, gold, carbon or any other suitable conductive materialmay be used to increase the resistance as may be desired. The bloodglucose meter may be configured such that the strip port includes acurrent connector and predetermined control lines that may be configuredto measure the resistance values coded on the test strips. Morespecifically, in one embodiment, the expiration dates may be coded usingthe resistance value on the wake-up bar in a logical sequence such asfollows:

Resistance Value Expiration Date 300-310 kOhm Q1 of odd year 315-320kOhm Q2 of odd year 350-360 kOhm Q1 of even year

Referring to FIGS. 9A-9C, it can be seen that the wavy lines mayincrease in thickness or length to change the resistance on the teststrip. Furthermore, the pads on the test strip are shown to make contactwith the wake-up bar on the strip port. By way of an example, FIG. 9Aillustrates 300 KOhm trace width, FIG. 9B illustrates 315 KOhm tracewidth, and FIG. 9C illustrates 350 KOhm trace width, each associatedwith a predefined expiration date as described above.

In this manner, in one embodiment of the present disclosure, expirationdate of test strips may be automatically detected so that the user isnotified of expired date of a given test strip before it used to testfor blood glucose levels. Moreover, while the automatic expirationdetection is described in conjunction with test strip and blood glucosemeters, within the scope of the present disclosure, other medical deviceor consumable items with expiration dates may benefit from the techniquedescribed herein.

Furthermore, within the scope of the present disclosure, the expirationtime information may be provided on the test strip using techniquesother than, for example, resistance values provided on the wake up bar.That is, the coded or stored expiration time information may be providedon the test strip or other medical components such as analyte sensors,catheters, medication cartridges, for example, using capacitance, orthermal coating. Accordingly, the expiration of the test strip orconsumable medical components may be readily and easily ascertained.

A method in one aspect of the present disclosure includes detecting apresence of a medical component, determining a resistance valueassociated with the medical component, retrieving a stored resistancevalue associated with a predetermined time information, comparing thedetermined resistance value to the stored resistance value, andgenerating an output signal based on the comparison.

The predetermined time information may include expiration informationassociated with the medical component.

The medical component may include one or more of an analyte sensor, ablood glucose test strip, a medication cartridge, an infusion deviceinfusion set, or a catheter.

The medical component may include a glucose test strip for determining aglucose level using a predetermined volume of blood sample, where thepredetermined volume may include 1.0 microliter or less of blood sample,0.5 microliter or less of blood sample, 0.25 microliter or less of bloodsample, or 0.1 microliter or less of blood sample. Additionaldescription related to using a small volume of sample to determineanalyte levels using in vitro analyte sensor is provided in U.S. Pat.Nos. 6,143,164 and 6,592,745, the disclosure of which is incorporatedherein by reference for all purposes.

The resistance value may be provided on the medical component, using forexample, silver, gold, carbon, one or more combinations thereof, or inkformulation based thereon.

The medical component may include a glucose test strip having a wake upbar, and further, where the resistance value is provided using inkformulation on the wake up bar.

The method may include outputting the generated output signal, where thegenerated output signal may include one or more of an audible signalsuch as an audible alarm, a visual signal such as, for example,graphical or text display of the information, or a vibratory signal.

The generated output signal may include a notification of the medicalcomponent expiration.

An apparatus in a further aspect of the present disclosure includes ahousing, a test strip port coupled to the housing for receiving a teststrip, a memory unit coupled to the housing, and a processing unitoperatively coupled to the memory unit, the test strip port and thehousing, the processing unit configured to detect a resistance valueassociated with the test strip, to retrieve a predetermined timeinformation associated with the detected resistance value, and togenerate an output signal based on the retrieved predetermined timeinformation.

The test strip may include a glucose test strip.

The memory unit may be configured to store a plurality of predeterminedresistance values, each associated with a respective predetermined timeinformation.

The predetermined time information may be associated with expirationinformation for the test strip.

The predetermined time information may include time and dateinformation.

The apparatus may include an output unit coupled to the housing, thedisplay unit configured to display the generated output signal, wherethe output unit may include one or more of an audible output unit, atextual output unit, a vibratory output unit, or a graphical outputunit.

The generated output signal may include a notification of the test stripexpiration information.

A method in a further embodiment may include detecting insertion of aglucose test strip, determining a resistance value associated with thetest strip, retrieving an expiration information associated with thedetermined resistance value, and generating an expiration notificationbased on the expiration information.

The resistance value may be provided on the test strip, for example,using ink formulation.

A therapy management system in one embodiment of the present disclosureincludes an infusion device including a processing unit configured toperform data processing, and a user interface unit operatively coupledto a processing unit, where the processing unit is configured to detecta location information associated with the infusion device for output tothe user interface unit.

The location information in one embodiment is time based.

In one aspect, the location information is associated with a local timeinformation based on the location of the infusion device, where thelocation information may be received from a global positioning system(GPS) or from another device, such as a mobile telephone, a GPS enabledpersonal digital assistant, which has received that information from aglobal positioning system.

In one aspect, a clock unit may be operatively coupled to the processingunit, where the clock unit is configured to dynamically adjust thelocation information based on the location of the infusion device.

In a further embodiment, the clock unit may include an atomic clock.

The processor unit may be configured to generate a notificationassociated with the detected location information for output to the userinterface unit, where the notification may be output to the userinterface unit as one or more of a date information and time informationassociated with the location of the infusion device.

The processing unit may be configured to retrieve one or more programmedprocedures associated with time, where the one or more programmedprocedures may include one or more basal profiles, a programmed bolusdetermination schedule, a time based condition alert.

The time based condition alert may include one or more of a time basedreminder associated with the operation of the infusion device. Further,the time based condition alert may include one or more of a time basedreminder associated with the condition of the infusion device user.

In a further aspect, the processor unit may be configured toautomatically adjust one or more time based functions associated withthe operation of the infusion device based on the detected locationinformation.

A method in accordance with another embodiment includes detecting achange in the location information of a therapy management device,comparing the detected change with a stored location information, andexecuting one or more processes associated with the operation of thetherapy management device based on the detected change.

The detected change in the location information may include one of atime zone change, a time standard change, a date change, or combinationsthereof.

The one or more processes may include generating a notificationassociated with the detected change in the location information.

Further, the one or more processes may include modifying one or moreprogrammed time based functions of the therapy management device andwhich may include one or more of a programmed time based alert, aprogrammed time based fluid delivery determination; a programmed timebased fluid delivery profile, or a programmed time based operationalcondition of the therapy management device.

In still another aspect, the therapy management device may include oneor more of an infusion device or an analyte monitoring unit.

A therapy management system in accordance with still another embodimentof the present disclosure includes an infusion device, and acommunication unit operatively coupled to the infusion device over awireless data network, the communication device configured to transmit arequest for synchronization to the infusion device, where the infusiondevice may be configured to transmit one or more data to thecommunication unit in response to the received synchronization request.

The wireless data network may be based on one or more of a Bluetooth®communication protocol, an RF communication protocol, an infraredcommunication protocol, a Zigbee® communication protocol, an 802.1xcommunication protocol, or a wireless personal area network such as ANTprotocol.

In a further aspect, the wireless data network may include one or moreof a wireless local area network, or a WiFi network.

The communication unit may be configured to periodically transmit thesynchronization request at a predetermined time interval.

Further, the infusion device may be configured to verify the receivedsynchronization request before transmitting the one or more data to thecommunication unit.

The transmitted one or more data to the communication unit may beencrypted, and also, the communication unit may be configured to decryptthe received one or more encrypted data.

The transmitted one or more data may include one or more informationassociated with the stored user profile of the infusion device, anoperating parameter of the infusion device, or infusion deliveryinformation.

The communication unit may include one or more of an analyte monitoringunit, a personal digital assistant, a mobile telephone, a computerterminal, a server terminal or an additional infusion device.

A system for communicating with an infusion device in still anotherembodiment of the present disclosure includes a voice enabled device andan infusion device configured to communicate with the voice enableddevice using one or more voice signals.

In one aspect, the voice enabled device may include one or more of atelephone set, a mobile telephone, a voice of IP (Internet Protocol)telephone, a voice enabled computing device, or a voice enabled computerterminal.

The infusion device may be configured to initiate a voice enabledcommunication to the voice enabled device. For example, the infusiondevice may be integrated with mobile telephone components.

In one aspect, the voice enabled communication may include a telephonecall.

The infusion device may be configured to receive one or more voicecommands from the voice enabled device, where the infusion device may beconfigured to process the one or more voice commands to execute one ormore associated functions of the infusion device operation.

The one or more associated functions include a bolus dosagedetermination, a programmable notification, or a temporarily basaldosage determination.

A method in accordance with yet still another embodiment of the presentdisclosure includes initiating a voice signal based communication froman infusion device, and transmitting a voice signal associated with theoperation of the infusion device.

The method may also include receiving a voice signal based request overa communication network, and executing one or more functions associatedwith the operation of the infusion device based on the received voicesignal based request.

The voice signal based communication may include a telephone call.

A therapy management kit in accordance with still yet another embodimentincludes an infusion device including a processing unit configured toperform data processing, and a user interface unit operatively coupledto a processing unit, where the processing unit is configured to detecta location information associated with the infusion device for output tothe user interface unit.

The kit may further include a clock unit operatively coupled to theprocessing unit, where the clock unit is configured to dynamicallyadjust the location information based on the location of the infusiondevice.

The clock unit may include an atomic clock.

In a further aspect, the kit may also include a voice enabled device,where the infusion device may be further configured to communicate withthe voice enabled device using one or more voice signals.

In one aspect, the voice enabled device may include one or more of atelephone set, a mobile telephone, a voice of IP (Internet Protocol)telephone, a voice enabled computing device, or a voice enabled computerterminal.

The various processes described above including the processes performedby the processor 210 in the software application execution environmentin the fluid delivery device 120 as well as any other suitable orsimilar processing units embodied in the analyte monitoring system 120and the remote terminal 140, including the processes and routinesdescribed in conjunction with FIGS. 3-8, may be embodied as computerprograms developed using an object oriented language that allows themodeling of complex systems with modular objects to create abstractionsthat are representative of real world, physical objects and theirinterrelationships. The software required to carry out the inventiveprocess, which may be stored in the memory unit 240 (or similar storagedevices in the analyte monitoring system 110 or the remote terminal 140)of the processor 210, may be developed by a person of ordinary skill inthe art and may include one or more computer program products.

In addition, all references cited above herein, in addition to thebackground and summary of the invention sections, are herebyincorporated by reference into the detailed description of the preferredembodiments as disclosing alternative embodiments and components.

Various other modifications and alterations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments. It isintended that the following claims define the scope of the presentdisclosure and that structures and methods within the scope of theseclaims and their equivalents be covered thereby.

1. A device, comprising: a user interface to receive a user input, andto output information related to the operation of the device; acommunication component to receive glucose data based on signalsgenerated by an in vivo glucose sensor; one or more processors; and amemory storing instructions which, when executed by the one or moreprocessors, cause the one or more processors to: store the informationrelated to the operation of the device in the memory, and determine achange in environment in which the device is operating, and in responseobtain time data and update the stored information based on the timedata.
 2. The device of claim 1, wherein the change in environmentcorresponds to a change in time zone in which the device is operating.3. The device of claim 1, wherein the change in environment correspondsto a change in altitude of the device location.
 4. The device of claim1, wherein the information related to the operation of the device isinformation for a therapy profile for a user.
 5. The device of claim 1,wherein the communication component is configured to receive the glucosedata over at least one of an RF communication link, a Bluetoothcommunication link, or an infrared communication link.
 6. The device ofclaim 1, wherein the in vivo glucose sensor comprises a plurality ofelectrodes including a working electrode comprising ananalyte-responsive enzyme bonded to a polymer disposed on the workingelectrode.
 7. The device of claim 6, wherein the analyte-responsiveenzyme is chemically bonded to the polymer.
 8. The device of claim 6,wherein the working electrode further comprises a mediator.
 9. Thedevice of claim 1, wherein the in vivo glucose sensor comprises aplurality of electrodes including a working electrode comprising amediator bonded to a polymer disposed on the working electrode.
 10. Thedevice of claim 9, wherein the mediator is chemically bonded to thepolymer.
 11. A system, comprising: an in vivo glucose sensor; and areceiving device, comprising: a user interface to receive a user input,and to output information related to the operation of the receivingdevice; a communication component to receive glucose data based onsignals generated by the in vivo glucose sensor; one or more processors;and a memory storing instructions which, when executed by the one ormore processors, cause the one or more processors to: store theinformation related to the operation of the receiving device in thememory, and determine a change in environment in which the receivingdevice is operating, and in response obtain time data and update thestored information based on the time data.
 12. The system of claim 11,wherein the change in environment corresponds to a change in time zonein which the receiving device is operating.
 13. The system of claim 11,wherein the change in environment corresponds to a change in altitude ofthe receiving device location.
 14. The system of claim 11, wherein theinformation related to the operation of the receiving device isinformation for a therapy profile for a user.
 15. The system of claim11, wherein the communication component is configured to receive theglucose data over at least one of an RF communication link, a Bluetoothcommunication link, or an infrared communication link.
 16. The system ofclaim 11, wherein the in vivo glucose sensor comprises a plurality ofelectrodes including a working electrode comprising ananalyte-responsive enzyme bonded to a polymer disposed on the workingelectrode.
 17. The system of claim 16, wherein the analyte-responsiveenzyme is chemically bonded to the polymer.
 18. The system of claim 16,wherein the working electrode further comprises a mediator.
 19. Thesystem of claim 11, wherein the in vivo glucose sensor comprises aplurality of electrodes including a working electrode comprising amediator bonded to a polymer disposed on the working electrode.
 20. Thesystem of claim 19, wherein the mediator is chemically bonded to thepolymer.